Status: Closed
Activation Date: 2008APR02
Closing Date: 2011DEC14
Phase: III
Description: A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (with platinum-based chemotherapy) and Concurrent and Maintenance Cediranib in Women with Platinum-sensitive Relapsed Ovarian Cancer
Eligibility: Patients with relapsed epithelial ovarian, fallopian tube or primary serous peritoneal carcinoma who require platinum-based chemotherapy for first relapse 6 or more months after the last dose of first-line platinum-based therapy.
Objective: Primary: Overall Survival, Progression-free survival and tolerability. Secondary: Toxicity, Quality of Life, Health Economics and Molecular Biology.
Participation: Limited to invited centres
Lay Description: The purpose of this study is to investigate whether we can improve the benefits of chemotherapy treatment by adding a new drug called cediranib (AZD2171). Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there are good scientific reasons from laboratory studies why cediranib (AZD2171) should work on ovarian cancer cells, it has not yet been tested in a large number of women with ovarian cancer. Some early clinical studies have shown that cediranib (AZD2171) does have an effect on tumours, but we don't yet know whether the drug will be effective in treating ovarian cancer and, if it does work, for how long treatment should continue. For this reason, some women will receive standard chemotherapy drugs alone; some women will receive the new drug (cediranib) during chemotherapy; and, some women will receive the new drug (cediranib) during and after chemotherapy, for up to 18 months in total.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GYNECOLOGIC | OV18 | 87 | 32 | 42 | 68 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GYNECOLOGIC | OV18 | 87 | 1 | 5 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GYNECOLOGIC | OV18 | 87 | 74 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |